Impax Hires Specialists to Help Sort Manufacturing Issues
22-May-2013 - Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its California facility.
Bioartificial Liver Project Looks to Disposable Bioreactors for Large Scale Cultures
22-May-2013 - Disposable bioreactors could be the centerpiece of a project to develop and harvest large quantities of cells that eventually will be used in bioartificial livers for patients with severe liver failure.
EMA Biosimilars Draft: Non-EU Reference Avoids Clinical Trial Repeats
21-May-2013 - The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances.
Lonza Not 'Shellfish' When it Comes to Endotoxin QC Testing
21-May-2013 - Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.
US House Bill Aims to Expand Release of Clinical Trials Data
21-May-2013 - US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected.
Russia Working to Align Biologics Regs with International Standards
20-May-2013 - Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.
Hikma is Latest Firm to Stop Drugs Being Sold for Lethal Injections
20-May-2013 - Hikma has become the latest injectable manufacturer to take measures to stop its drugs being used in lethal injections.
Janssen's Manufacturing Problems May Lead to Criminal Charges in Korea
20-May-2013 - Though Janssen Korea says it is confident it will resolve its manufacturing issues, product recall and suspensions could be followed by lawsuits and imprisonment.
People on the Move: Pharma Jobs
20-May-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Bayer, Valeant and Eisai.
EMD Millipore Talks New Single-Use Chromatography Tech
20-May-2013 - EMD Millipore says its new chromatography tech can help manufacturers avoid compromising their processes when switching from multi-use to single use
Pfizer Puts Lipitor Site Up For Sale as Patent Expiration Causes Over-Capacity
16-May-2013 - Lower sales of off-patent former blockbuster Lipitor have prompted Pfizer to try and sell off its third Irish API plant in as many years.
Chewing gum developed to battle common cold
16-May-2013 - Private label gum maker Fertin Pharma has developed an immunity chewing gum that it claims can help guard against the common cold.
UK Animal Research Labelling Plan Must Not Put Patients Off Treatment, Says ABPI
16-May-2013 - New UK proposals to label all drugs as “produced as a result of research on animals” have met with muted response from pharmaceutical industry group, the ABPI.
US House Committee Advances Track-and-Trace Legislation
16-May-2013 - The US House Energy & Commerce Committee on Wednesday advanced a bill to further secure the US prescription drug supply chain, though it stops short of mandating unit-level, electronic tracking and tracing of drugs.
Coalition Calls for Science-Based Approach to Elemental Impurity Testing
15-May-2013 - Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.
West Adds Second Filling line in Prep for Future Crystal Zenith Boom
15-May-2013 - Extra filling capacity is to be made available in preparation for West’s Crystal Zenith (CZ) system, though approval and increased sales are still at least 18 months away.
ATMI: Single-Use Could Replace Multi-Use, as Potency Increases
15-May-2013 - Single-use is set to dominate biopharma processing as products become more potent resulting in smaller volumes, according to ATMI.
Ranbaxy Pleads Guilty to Manufacturing Adulterated Drugs
15-May-2013 - In the largest US generic drug safety settlement ever, Ranbaxy USA has agreed to pay $500m after pleading guilty to manufacturing and distributing adulterated drugs, according to the US Justice Department settlement agreement.
Aesica Accesses Atom-Efficient Amide Tech in Academic Accord
14-May-2013 - Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.
Canada Solidifies GMP Requirements for APIs to Secure Supply Chain
14-May-2013 - Looking to align with other industrialized nations, Canada has agreed to extend its GMP requirements for all active pharmaceutical ingredients (APIs), according to a notice in the Canada Gazette.